US Patent Granted to ScinoPharm for the Production of SN-38.TAIPEI -- ScinoPharm has just been awarded an US patent that relates to the preparation of SN-38, a key intermediate in the synthesis of irinotecan. The US patent, No. 7,151,179, entitled "Process for the Preparation of 7-Alkyl-10-Hydroxy-20(S)-Camptothecin," was issued on December 19, 2006 by the US Patent and Trademark Office (PTO PTO abbr. 1. Parent Teacher Organization 2. or p.t.o. please turn over 3. power takeoff PTO or pto please turn over Noun 1. ). SN-38, the active metabolite active metabolite Therapeutics A drug metabolite with therapeutic activity similar to the parent compound, which must be considered in therapeutic pharmacokinetics of irinotecan (CPT-11), is widely used by many new drug companies to develop new camptothecin derivatives. ScinoPharm's proprietary process, circumventing the previous photo chemistry, leads to an enhanced efficiency in the synthesis of SN-38, and hence improves also the cost-efficiency of manufacturing irinotecan as a whole. "The newly granted patent ensures our competitive edge as one of the leading manufacturers and suppliers for irinotecan," said Dr. Hardy Chan, Executive Vice President and CSO (Chief Security Officer) The person in charge of all staff members who are responsible for promulgating, enforcing and administering security policies for all systems within an enterprise or division. of ScinoPharm. "Aside from the cost-efficiency, this proprietary process also provides a safeguard to our customers without infringement concerns," he added. ScinoPharm is the first filer of Drug Master File Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. (DMF (Distribution Media Format) A floppy disk format from Microsoft that was used to distribute its software. DMF floppies compressed more data (1.7MB) onto the 3.5" diskette, and the files could not be copied with normal DOS and Windows commands. A DMF utility had to be used. ) for irinotecan HCI (Human Computer Interaction) Refers to the design and implementation of computer systems that people interact with. It includes desktop systems as well as embedded systems in all kinds of devices. with the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). So far, the company has filed DMF registrations for its irinotecan HCI in 32 other countries where DMF registrations are prerequisites to receiving approvals to market irinotecan HCI after substance patent expirations. ScinoParm now has 8 patents granted, and 10 additional patents pending with the US Patent Office and its counterparts worldwide. The company's patent portfolio is centered on process innovation in the syntheses of advanced intermediates and active pharmaceutical ingredients. About ScinoPharm Taiwan ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry. ScinoPharm currently serves more than 135 customers worldwide, including some of the largest brand companies and almost all major generic companies. ScinoPharm has also developed a broad portfolio of API products in the oncological, hormonal, antibiotics, and CNS See Continuous net settlement. CNS See continuous net settlement (CNS). arenas. To enable timely market launch, the company has been filing DMFs in as many countries as possible. To date, it has over 170 DMF registrations worldwide, 22 of which were filed in the US. For more information, please visit the company's web site at http://www.scinopharm.com. |
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